PARP inhibitor induced nausea and vomiting program is now clinically ready to advance to Phase 3.
DECEMBER 18 2019, NEW YORK – ChemioCare USA Inc. (“ChemioCare” or the “Company”), a biotechnology company focused on transforming standard of care therapeutics, today announced the completion of a human bioavailability study of CMIO-OLNZ, a 7-day matrix transdermal delivery system of olanzapine for the treatment of poly ADP ribose polymerase (PARP) inhibitor induced nausea and vomiting (PIINV) (the “Study”). This first-in-woman study demonstrated that CMIO-OLNZ delivers target therapeutic levels of olanzapine over 7 days, is well-tolerated to the skin, adheres to the skin over the dosing interval with easy removal, and has lower overall sedation side effect intensity – when compared to ZYPREXA oral. All endpoints and objectives of the study were met and the product is now clinically ready to advance to its Phase 3 clinical study.
The randomized, open-label Study was a comparative bioavailability (BA) study in 36 healthy female volunteers to characterize the olanzapine systemic exposure profile to the proposed formulation of two different sizes of an Olanzapine TDS applied for 7-days compared to that of a once daily 7-day regimen of olanzapine 10 mg/day (ZYPREXA). The Study evaluated plasma olanzapine concentration over the dosing interval, as well as safety assessments including sedation and skin irritation.
Olanzapine plasma concentrations observed were within the target range for therapeutic efficacy. These results will inform the patch size to be manufactured for the planned Phase 3 clinical study. Sedation scores among CMIO-OLNZ cohorts were substantially lower than in the oral ZYPREXA cohort.
The patch site was assessed for skin irritation using the Draize skin irritation scale. The average total score indicates only very mild, transient irritation. Patch adhesion was reliable over the duration of the study with no patch failures reported.
“These results demonstrate that CMIO-OLNZ can provide sufficient blood levels to achieve sustained efficacy in PIINV without sedation,” said Jamie Oliver, Chief Medical Officer. “Over 70% of patients treated with PARP inhibitors experience chronic nausea, leading to dose interruptions and discontinuations in up to 17% of patients. There are no antiemetics approved or suited for use in this setting, representing a serious unmet medical need among these cancer patients.”
Pedro Lichtinger, Chairman and CEO added, “This is a remarkable achievement for our young company having moved to a clinically Phase 3-ready program in just two and a half years. This data supports the initiation of a crossover financing leading towards an IPO potentially in 2020.”
ChemioCare received an exemption from the U.S. Food and Drug Administration (the “FDA”) from the requirements for an Investigational New Drug application (“IND”) to execute the BA study in healthy volunteers.
ChemioCare is a clinical-stage biotechnology company focused on transforming standard of care therapeutics with a focus on hematology and oncology. ChemioCare uses proven transdermal technology with proprietary drivers to obtain new indications or develop on-label superiority. To learn more, visit www.chemio.care
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ZYPREXA is a trademark of Eli Lilly and Company
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